MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NAIL CAP 5MM; NAIL, FIXATION, BONE

Model Number 71634005

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2021

Event Type  malfunction  

Event Description

It was reported that, during surgery, the nail cap 5mm cannot fit into the tibia nail.The procedure was finished with a smith and nephew back up device without delay.The patient was not harmed.

Manufacturer Narrative

Internal complaint reference case: (b)(4).

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.A visual inspection was conducted and confirmed that the inner part of the nail cap has deformation, rendering the device inoperable.This device also shows signs of significant wear and usage.A review of complaint history did not reveal similar events for the listed batch and part number.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.Possible causes could include but not limited to surgical technique used or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: NAIL CAP 5MM
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13113851
• MDR Text Key: 285157883
• Report Number: 1020279-2021-08965
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 03596010495716
• UDI-Public: 03596010495716
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K981529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71634005
• Device Catalogue Number: 71634005
• Device Lot Number: 21AM06966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1